[ Looks like they're not trying to hide the bullshit like they used to. - SD]
From:
https://tinyurl.com/4ad9dduf (theepochtimes.com)
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CDC Issues New COVID-19 Guidance After FDA Makes Change
By Jack Phillips
January 29, 2023
The Centers for Disease Control and Prevention ([100]CDC) issued new
guidance to people with weak immune systems, saying they should take extra
precautions after a key [101]COVID-19 antibody treatment's emergency use
authorization was pulled by another federal agency.
The guidance again calls for immunocompromised individuals to wear masks
and engage in social distancing, the CDC's revised guidance says, despite
CDC-cited [102]studies and data suggesting that masks provide little
effectiveness in blocking the transmission of COVID-19. Some former
federal officials have said that the six-foot social distancing rule
adopted around the United States in early 2020 was arbitrary.
Last week, the U.S. Food and Drug Administration ([103]FDA) [104]pulled
its authorization of Evusheld, a combination antibody treatment that is
given to people with weak immune systems. The agency said that it is not
effective against most of the COVID-19 Omicron subvariants that are
currently circulating around the United States, including the XBB
subvariants and the BQ strain.
"Among persons with immunocompromise and their household members and close
contacts, prevention measures including wearing a high-quality and
well-fitting mask, maintaining physical distance from others (at least six
feet), improving indoor ventilation, practicing frequent handwashing, and
developing a care plan, should be considered in addition to receipt of a
bivalent booster dose," said the CDC on Jan. 27.
The agency added that "it is important to wear a mask and maintain
physical distance from others if it is not possible to avoid crowded
indoor spaces ... simple interventions should be used to improve
ventilation in buildings and decrease SARS-CoV-2 transmission by improving
air flow." The agency also again recommended that immunocompromised people
should get up-to-date COVID-19 vaccines.
The CDC advises that people who have a weak immune system and develop
COVID-19-like symptoms to get tested for the virus. They should then
receive an antiviral drug within five to seven days.
"Early outpatient treatment of mild to moderate COVID-19 with a
recommended first-line therapy, ritonavir-boosted nirmatrelvir (Paxlovid),
or remdesivir (Veklury), or the second-line therapy, molnupiravir
(Lagevrio), have been shown to reduce the risk for severe COVID-19,
including hospitalization and death," it says. Some doctors have
[105]expressed concerns about remdesivir, claiming the drug has
potentially fatal side-effects like kidney failure.
About 7 million people in the United States have a condition that greatly
compromises their immune system, such as cancer, according to CDC figures.
FDA Pulls Authorization
Evusheld, which the FDA pulled on Jan. 26, is manufactured by AstraZeneca,
and it was first authorized in December 2021 as a pre-exposure prophylaxis
against COVID-19 for people with weak immune systems and aren't likely to
generate COVID-19 antibodies via vaccination.
The agency said that as of now, the drug cannot neutralize a number of
Omicron subvariants like BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6,
BA.2.75.2, XBB, and XBB.1.5.
"This means that Evusheld is not expected to provide protection against
developing COVID-19 if exposed to those variants," the FDA said in a press
release explaining why the drug is being pulled.
"Today's action to limit the use of Evusheld prevents exposing patients to
possible side effects of Evusheld such as allergic reactions, which can be
potentially serious, at a time when fewer than 10 percent of circulating
variants in the U.S. causing infection are susceptible to the product,"
the press release stated.
AstraZeneca, the British-Swedish drug giant that also makes a commonly
used COVID-19 vaccine, said it was informed that the agency will decide
about reinstating authorization of Evusheld if the prevalence of resistant
variants in the United States decreases to 90 percent or less on a
sustained basis. The drugmaker plans to continue to share relevant data
with the FDA and other health authorities regarding Evusheld and
SARS-CoV-2 variants.
Monoclonal antibodies act by binding to the spike protein on the surface
of the SARS-CoV-2 virus, but the virus has been evolving, causing changes
in this protein and affecting how the antibodies work against them.
"AstraZeneca will continue to work with the FDA and other health
authorities to collect, assess and share relevant data regarding Evusheld
and SARS-CoV-2 variants," the first said in a statement. "Evusheld
currently remains authorized in other countries where it is approved for
COVID-19 pre-exposure prophylaxis and treatment, including the EU and
Japan."
In November, the U.S. health regulator also pulled emergency use
authorization for Eli Lilly and Co's COVID-19 drug bebtelovimab, citing
similar concerns.
Links:
100.
https://www.theepochtimes.com/t-cdc
101.
https://www.theepochtimes.com/t-covid-19
102.
https://www.theepochtimes.com/fauci-couldnt-name-any-studies-showing- masks-work-against-covid-19-lawyers_4888725.html
103.
https://www.theepochtimes.com/t-fda
104.
https://www.theepochtimes.com/fda-pulls-authorization-for-evusheld-says -its-ineffective-against-new-covid-mutations_5015212.html
105.
https://www.theepochtimes.com/health/controversial-drug-remdesivir -plays-key-role-in-covid-related-hospital-deaths-dr-ardis_4646394.html
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- Sean
... Be a team player. It spreads out the blame.
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